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Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01170338
Recruitment Status : Unknown
Verified July 2010 by Newark Beth Israel Medical Center.
Recruitment status was:  Recruiting
First Posted : July 27, 2010
Last Update Posted : July 27, 2010
Sponsor:
Information provided by:
Newark Beth Israel Medical Center

Tracking Information
First Submitted Date  ICMJE July 26, 2010
First Posted Date  ICMJE July 27, 2010
Last Update Posted Date July 27, 2010
Study Start Date  ICMJE January 2008
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
nicotine levels [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
recurrent myocardial ischemia [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome
Official Title  ICMJE Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome
Brief Summary Assess the role of a nicotine antagonist in helping patients presenting to hospital with acute coronary syndrome to stop smoking.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Smoking
  • Acute Coronary Syndrome
Intervention  ICMJE
  • Drug: Varenicline 100 mg by mouth twice daily
    this is an active drug to help smoking cessation
  • Drug: control
    this is the placebo that will help us maintain a blinded study
Study Arms  ICMJE
  • Experimental: active Chantix
    active drug to help smoking cessation
    Intervention: Drug: Varenicline 100 mg by mouth twice daily
  • Placebo Comparator: sugar pill
    Intervention: Drug: control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 26, 2010)
100
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • active smokers presenting to hospital with an acute coronary syndrome

Exclusion Criteria:

  • patients with an acute coronary syndrome who are not active smokers
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01170338
Other Study ID Numbers  ICMJE 2008.68
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marc Cohen, MD, Newark Beth Israel Medical Ctr
Study Sponsor  ICMJE Newark Beth Israel Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Newark Beth Israel Medical Center
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP